Attachment A3 final 60 day notice

28867

Federal Register / Vol. 71, No. 96 / Thursday, May 18, 2006 / Notices
As defined in the proposed order,
‘‘competent and reliable scientific
evidence’’ means tests, analyses,
research, studies, or other evidence,
based on the expertise of professionals
in the relevant area, that has been
conducted and evaluated in an objective
manner by persons qualified to do so,
using procedures generally accepted in
the profession to yield accurate and
reliable results. A ‘‘substantially similar
product’’ means any product that is
substantially similar in ingredients,
composition, and properties to any of
the six products challenged in the
Complaint.
Paragraph V provides that Basic
Research will pay the sum of three
million dollars ($3,000,000), on behalf
of all Respondents, to the Commission.
In the discretion of the Commission,
these funds may be used to provide
redress to purchasers of any of the
products challenged in the Complaint
and to pay the attendant administrative
costs. If the Commission determines, in
its sole discretion, that redress to
product purchasers is wholly or
partially impracticable or is otherwise
unwarranted, any funds not used will be
paid to the U.S. Treasury.
The proposed order allows
Respondents to engage in various forms
of legitimate conduct. The order does
not prohibit Respondents from making
any claim for any drug that is permitted
in labeling for that drug under any
tentative final or final standard
established by the Food and Drug
Administration (‘‘FDA’’), or under any
new drug application approved by the
FDA (Paragraph VI of the proposed
order). The order also does not prohibit
Respondents from making any claim for
any product that is specifically
permitted in labeling for that product
under FDA regulations made under the
Nutrition Labeling and Education Act of
1990 (Paragraph VII of the proposed
order).
Additionally, Paragraphs VIII, IX, X,
and XI provide for various compliance
reports and notifications by the
Respondents. Paragraph XII obligates
the Respondents to cooperate in certain
ways with any Commission inquiry into
their compliance with the order. The
proposed order will expire in 20 years.

By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. E6–7533 Filed 5–17–06; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[60Day–06–06BG]

Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Seleda Perryman,
CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS–D74,
Atlanta, GA 30333 or send an e-mail to
[email protected].
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.
Proposed Project
Longitudinal Follow-up of Youth with
Attention-Deficit/Hyperactivity Disorder
(ADHD) Identified in Community
No. of
respondents

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Health Risk Behavior Survey (Parent Report) .................................................
Health Risk Behavior Survey (Youth Report) ..................................................
Demographics and Family History Survey (Parent) ........................................
Treatment and Services Survey ......................................................................

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Background and Brief Description

Centers for Disease Control and
Prevention

Respondents

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Settings: Examining Health Status,
Correlates, and Effects Associated with
Treatment for ADHD—New—National
Center on Birth Defects and
Developmental Disabilities (NCBDDD),
Centers for Disease Control and
Prevention (CDC).

This project will collect data from
proxy respondents and youths with and
without Attention-Deficit/Hyperactivity
Disorder (ADHD). This program
addresses the Healthy People 2010 focus
area of Mental Health and Mental
Disorders, and describes the prevalence,
incidence, long-term outcomes,
treatment(s), select co-morbid
conditions, secondary conditions, and
health risk behavior of youth with
ADHD relative to youth without ADHD.
In FY 2002–FY 2005 two cooperative
agreements (transitioned to extramural
research) were awarded to conduct
community-based epidemiological
research on ADHD among elementaryaged youth, known as the Project to
Learn about ADHD in Youth (PLAY
Study Collaborative, OMB# 0920–0584,
expired on March 31, 2006). These
studies provided community-based
prevalence, rates of co-morbidity, and
rates of health risk behaviors among
elementary-age youth with and without
ADHD as determined by a rigorous case
definition developed by the principal
investigators in collaboration with CDC
scientists.
The purpose of this program is to
study the long-term outcomes and
health status for children with ADHD
identified and treated in community
settings through a systematic follow-up
of the subjects who participated in the
PLAY Study Collaborative. There is
considerable interest in the long-term
outcomes of youth with ADHD as well
as the effects of treatment, lack of
treatment, and quality of care in average
U.S. communities, emphasizing the
public health importance of
longitudinal research in this area. There
are no costs to the respondents other
than their time.
Estimated Annualized Burden Hours
Average
burden per
response
(in hrs.)

No. of responses per
respondent

980
980
980
980

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1
1
1

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10/60
10/60
15/60
10/60

Total burden
hours
163
163
245
163

28868

Federal Register / Vol. 71, No. 96 / Thursday, May 18, 2006 / Notices

Respondents

Total ..........................................................................................................

Dated: May 11, 2006.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E6–7562 Filed 5–17–06; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

No. of responses per
respondent

Average
burden per
response
(in hrs.)

........................

........................

........................

ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.

Proposed Data Collections Submitted
for Public Comment and
Recommendations

Proposed Project
Importation of Etiologic Agents,
Hosts, and Vectors of Human Disease
(42 CFR 71.54)—(OMB Control No.
0920–0199)—Revision—Office of the
Director (OD), Centers for Disease
Control (CDC).

In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Seleda Perryman,
CDC Assistant Reports Clearance
Officer, 1600 Clifton Road, MS–D74,
Atlanta, GA 30333 or send an e-mail to
[email protected].
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)

Background and Brief Description
The Foreign Quarantine Regulations
(42 CFR part 71) set forth provisions to
prevent the introduction, transmission,
and spread of communicable disease
from foreign countries into the United
States. Subpart F—Importations—
contains provisions for importation of
etiologic agents, hosts, and vectors (42
CFR 71.54), requiring persons that
import or distribute after importing
these materials to obtain a permit issued
by the CDC. This request is for the
information collection requirements
contained in 42 CFR 71.54 for issuance
of permits by CDC to importers or
distributors after importation of
etiologic agents, hosts, or vectors of
human disease.
CDC is requesting continued OMB
approval to collect this information
through the use of two separate forms.
These forms are: (1) Application for
Permit to Import or Transport Etiologic
Agents, Hosts, or Vectors of Human

Centers for Disease Control and
Prevention
[60Day-06–0199]

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No. of
respondents

Total burden
hours
734

Disease and (2) Application for Permit
to Import or Transport Live Bats.
The Application for Permit to Import
or Transport Etiologic Agents, Hosts, or
Vectors of Human Disease will be used
by laboratory facilities, such as those
operated by government agencies,
universities, research institutions, and
zoologic exhibitions, and also by
importers of nonhuman primate trophy
materials, such as hunters or
taxidermists, to request permits for the
importation and subsequent distribution
after importation of etiologic agents,
hosts, or vectors of human disease. The
Application for Permit to Import or
Transport Etiologic Agents, Hosts, or
Vectors of Human Disease requests
applicant and sender contact
information; description of material for
importation; facility isolation and
containment information; and personnel
qualifications.
The Application for Permit to Import
or Transport Live Bats will be used by
laboratory facilities such as those
operated by government agencies,
universities, research institutions, and
zoologic exhibitions entities to request
importation and subsequent distribution
after importation of live bats. The
Application for Permit to Import or
Transport Live Bats requests applicant
and sender contact information; a
description and intended use of bats to
be imported; facility isolation and
containment information; and personnel
qualifications. Estimated average time to
complete this form is 20 minutes. There
are no costs to respondents other than
their time.
Estimated Annualized Burden Hours

CFR section

Number of
respondents

Responses
per
respondent

Avg. burden
response
(in hours)

Total burden
hours

71.54 Application for Permit ............................................................................

2,300

1

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